The study will test the hypothesis that supplementing the diet of subjects with Metabolic Syndrome with 2000 IU vitamin D and 1.8 g omega-3 fatty acids (EPA + DHA) per day, will facilitate weight loss, improve body composition and reduce metabolic and biochemical risk factors associated with type II diabetes and cardiovascular disease. Adult men and women who meet the International Diabetes Federation criteria for Metabolic Syndrome will be enrolled and embark on a 16 week diet and exercise intervention using a low glycemic index diet with or without the supplementary vitamin D and omega-3. Subjects will be counseled weekly and blood collected at weeks 0 and 16.

a low glycemic diet, calorie restricted with exercise sessions 3 times per week

Active Comparator: supplemented

2000 IU vitamin D3 plus 1.8 g EPA + DHA

Other: low glycemic diet

a low glycemic diet, calorie restricted with exercise sessions 3 times per week

Dietary Supplement: vitamin D omega-3

2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

must have Metabolic Syndrome as defined by International Diabetes Federation

must be able to swallow tablets and capsules

must be 18 years of age or older

must be physically capable of moderate intensity exercise

Exclusion Criteria:

pregnant or lactating

vegetarian

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326442